MalocclusionNCT02550938
Primer Aligner Study
A study testing Invisalign in people with Malocclusion, run by Align Technology, Inc. at 19 sites in 2 countries.
Trial summary
To demonstrate that a primer aligner product can achieve similar results to the currently marketed product. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Malocclusion
- What is being tested?
- Invisalign
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 253 participants
- Where
- 19 sitesin 2 countries
- Study dates
- May 2015to Sep 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject must have fully erupted dentition
- Age range ≥18 years old (Adult subject)
- Subjects who are indicated for either: 5, 7, 10, or 12 aligner sets
Who cannot join
- Subject who has unerupted, erupting, partially erupted dentition (except for 2nd and 3rd molars)
- Subject who has mixed dentition
- Subject with periodontal disease
- Subject with active caries
- Subject with Temporomandibular Joint Disorders symptoms
- Subject has undergone pre-treatment with any orthodontic appliance 3 months prior to the start of treatment
Show all 9Show fewer
- Subject has undergone any accelerated orthodontic treatment prior to or during treatment as part of this study
- Subject has known allergy to latex or plastic
- Subjects who are pregnant or will become pregnant during treatment
Trial locations and contacts
19 sites in 2 countries.
19 sites in 2 countries
United States13 sites
Wood Orthodontics
Anthem, Arizona, 85086
DMG Dental Design
Bothell, Washington, 98012
Posner, Henderson & Goslee Dentistry
Bristol, Connecticut, 06010
Feldman Orthodontics
Cheshire, Connecticut, 06410
Comizio Orthodontics
Eastchester, New York, 10709
Magic Touch Orthodontist
Little Neck, New York, 11362
Wenger Orthodontics
Mayfield Heights, Ohio, 44124
Meadowbrook Dental Care
Mineola, New York, 11501
Cooke Orthodontics
Napa, California, 94558
The Orthodontic Center
Oakland, California, 94612
Dental One Reston
Reston, Virginia, 20191
Green Dentistry
San Francisco, California, 94108
Align Technology, Inc.
San Jose, California, 95131
United Kingdom6 sites
Brixworth Dental Practice
Brixworth, Northampton, NN6 9DS
Anglia Orthdontics
Cambridge, England, CB3 9PA
Bluebell Dental Practice
Chigwell, England, IG6 2QP
Cherrybank Dental Spa
Edinburgh, Scotland, EH3 5DQ
Dream Smile Dental Clinic
London, England, SE13 7FD
High Street Dental Care
Melton Mowbray, Leicestershire, LE13 0TR
About this study
To demonstrate that a primer aligner product can achieve similar results to the currently marketed product.
Read the detailed description
The Invisalign® System consists of a series of clear plastic aligners that are intended to replace conventional wire and bracket technology for many orthodontic cases. Each custom manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their original state to a final, treated state. Each aligner is worn for about two weeks, then replaced by the next in the series until the final position is achieved. For years, orthodontists and dentists have used removable appliances for orthodontic treatment. Today, with the application of computer technology and custom manufacturing, Invisalign treats a broader range of cases with greater precision.
- Conditions
- Malocclusion
- Being tested
- Invisalign
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InvisalignDevice
The Invisalign® System consists of a series of clear plastic aligners that are intended to replace conventional wire and bracket technology for many orthodontic cases. Each custom manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their original state to a final, treated state. Each aligner is worn for a defined period of time , then replaced by the next in the series until the final position is achieved. For years, orthodontists and dentists have used removable appliances for orthodontic treatment. Today, with the application of computer technology and custom manufacturing, Invisalign treats a broader range of cases with greater precision.
| Study group | Role | What they receive |
|---|---|---|
| 7 Aligner Cohort weartime 1 | Experimental | Seven Aligner cohort will change aligners at a designated interval Invisalign is the intervention. Receives: Device: Invisalign |
| 7 Aligner Cohort weartime 2 | Experimental | Seven Aligner cohort will change aligners at a modified interval Invisalign is the intervention. Receives: Device: Invisalign |
| 12 aligner cohort weartime 1 | Experimental | Twelve Aligner cohort will change aligners at a designated interval Invisalign is the intervention. Receives: Device: Invisalign |
| 12 aligner cohort weartime 2 | Experimental | Twelve Aligner cohort will change aligners at a modified interval Invisalign is the intervention. Receives: Device: Invisalign |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Treatment Time
Total treatment time was measured in days. The less days a subject was in treatment, the better.
Measured: Approximately 1 year
Rate of Refinement
Rate of Refinement was how often subjects in each cohort required additional aligners in (in addition to their originally prescribed aligners) to treat the malocclusion. For example, if a subject was originally prescribed 20 aligners for treatment, but then needed 10 more aligners, the 10 extra aligners would be considered the "refinement." The Rate of Refinement for each cohort was measured as the total number of additional aligners required to complete orthodontic treatment divided by the total number of aligners that were initially prescribed to complete treatment, multiplied by 100. The smaller the rate of refinement (%), the better.
Measured: Approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2015 (estimated)
- Study startMay 2015
- Primary completionSep 2020
- Study completionSep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MalocclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 253 participants (actual)
Sponsor and investigators
- Lead sponsor
- Align Technology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ahmed Moneim, DDS, Principal investigator, Los Gatos Dental Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02550938
- Sponsor's protocol ID
- CSP-300307-00
- Status last verified
- Jan 2021
- First submitted
- 23 Jul 2015
- Last updated
- 3 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primer Aligner Study
- ClinicalTrials.gov ID
- NCT02550938
- Acronym / sponsor ID
- CSP-300307-00
- Conditions
- Malocclusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 253 participants (actual)
- Lead sponsor
- Align Technology, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- Sep 2020 (actual)
- Study completion
- Sep 2020 (actual)
- First posted
- 16 Sep 2015 (estimated)
- Results
- Posted 3 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To demonstrate that a primer aligner product can achieve similar results to the currently marketed product.
Detailed description
The Invisalign® System consists of a series of clear plastic aligners that are intended to replace conventional wire and bracket technology for many orthodontic cases. Each custom manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their original state to a final, treated state. Each aligner is worn for about two weeks, then replaced by the next in the series until the final position is achieved. For years, orthodontists and dentists have used removable appliances for orthodontic treatment. Today, with the application of computer technology and custom manufacturing, Invisalign treats a broader range of cases with greater precision.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 7 Aligner Cohort weartime 1 | Experimental | Device: InvisalignSeven Aligner cohort will change aligners at a designated interval Invisalign is the intervention. |
| 7 Aligner Cohort weartime 2 | Experimental | Device: InvisalignSeven Aligner cohort will change aligners at a modified interval Invisalign is the intervention. |
| 12 aligner cohort weartime 1 | Experimental | Device: InvisalignTwelve Aligner cohort will change aligners at a designated interval Invisalign is the intervention. |
| 12 aligner cohort weartime 2 | Experimental | Device: InvisalignTwelve Aligner cohort will change aligners at a modified interval Invisalign is the intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject must have fully erupted dentition
- Age range ≥18 years old (Adult subject)
- Subjects who are indicated for either: 5, 7, 10, or 12 aligner sets
Key exclusion criteria (9 listed)
- Subject who has unerupted, erupting, partially erupted dentition (except for 2nd and 3rd molars)
- Subject who has mixed dentition
- Subject with periodontal disease
- Subject with active caries
- Subject with Temporomandibular Joint Disorders symptoms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InvisalignThe Invisalign® System consists of a series of clear plastic aligners that are intended to replace conventional wire and bracket technology for many orthodontic cases. Each custom manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their original state to a final, treated state. Each aligner is worn for a defined period of time , then replaced by the next in the series until the final position is achieved. For years, orthodontists and dentists have used removable appliances for orthodontic treatment. Today, with the application of computer technology and custom manufacturing, Invisalign treats a broader range of cases with greater precision. | Device | 12 aligner cohort weartime 1, 12 aligner cohort weartime 2, 7 Aligner Cohort weartime 1, 7 Aligner Cohort weartime 2 |
Primary outcome
Total Treatment Time
Time frame: Approximately 1 year
Total treatment time was measured in days. The less days a subject was in treatment, the better.
Rate of Refinement
Time frame: Approximately 1 year
Rate of Refinement was how often subjects in each cohort required additional aligners in (in addition to their originally prescribed aligners) to treat the malocclusion. For example, if a subject was originally prescribed 20 aligners for treatment, but then needed 10 more aligners, the 10 extra aligners would be considered the "refinement." The Rate of Refinement for each cohort was measured as the total number of additional aligners required to complete orthodontic treatment divided by the total number of aligners that were initially prescribed to complete treatment, multiplied by 100. The smaller the rate of refinement (%), the better.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Moneim, DDS principal investigator
Los Gatos Dental Center
19 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Invisalign in people with Malocclusion, run by Align Technology, Inc. at 19 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Treatment Time (time frame: Approximately 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2021.